Intra-annular mounting frame for aortic valve repair

ABSTRACT

An intra-annular mounting frame for an aortic valve having native aortic cusps is provided which includes a frame body with native leaflet reorienting curvatures and interconnecting points; the curvatures shaped to be received inside the valve below the native aortic cusps and to reorient the native aortic cusps within the aortic valve, where each of the curvatures extends concavely upward from a reference latitudinal plane tangential to each curvature&#39;s base.

The present application is a continuation of and claims benefit ofco-pending U.S. patent application Ser. No. 13/453,914 entitled“Intra-Annular Ring For Aortic Valve Repair” filed Apr. 23, 2012 whichclaims priority to U.S. patent application Ser. No. 11/799,942 (nowissued as U.S. Pat. No. 8,163,011) entitled “Intra-Annular Ring ForAortic Valve Repair” filed May 5, 2007 which claims priority to U.S.provisional patent application Ser. No. 60/849,919, entitled“Intra-Annular Ring For Aortic Valve Repair” filed Oct. 6, 2006, each ofwhich are incorporated by reference in their entireties.

BACKGROUND OF THE INVENTION Technical Field

The present invention relates to a mounting frame useful forapplications including aortic valve repair. More particularly, thepresent invention relates to an intra-annular mounting frame which isinserted directly into the aortic valve annulus. The invention alsoincludes methods for the insertion and implantation of the intra-annularmounting frame, as well as complementary devices, such as ascendingaortic Dacron® grafts and pericardial single cusp prostheses.

Background of the Art

The mammalian heart is essentially a pump that functions as achemo-mechanical energy transducer. The chemical energy of metabolicsubstrates and oxygen is converted into the mechanical energy of bloodpressure and flow by myocardial sarcomeres during cardiac contraction.The pump is periodic at a frequency of 1-2 Hz, with thecontraction/ejection phase called systole and the relaxation/fillingphase termed diastole.

The human heart is the center of the cardiovascular system, the systemhaving two parallel circulations consisting of the pulmonary circulationand the systemic circulation. The pulmonary circulation receives bloodfrom the venae cavae into the right atrium and right ventricle, and thenpumps the cardiac output into the pulmonary arteries and through thelungs. The systemic circulation receives blood from the pulmonary veins,pumps the cardiac output through the left atrium and left ventricle tothe aorta, systemic arteries, capillaries, and veins, and finallytransmits blood back to the venae cavae. The mitral valve is positionedbetween the upper chamber, the left atrium, and the pumping chamber, theleft ventricle. The left atrium acts in a capacitor function receivingblood from the lungs via the pulmonary veins throughout the cardiaccycle. The left ventricle fills during diastole by receiving blood fromthe left atrium as the mitral valve opens, and then during systole, themitral valve closes and permits forward ejection of the blood from theleft ventricle into the ascending aorta. The aortic valve is locatedbetween the left ventricle and aorta, and functions under normalconditions to allow unimpeded blood flow out of the ventricle and intothe aorta during systole. During diastole, the aortic valve closes andprevents regurgitation backward into the left ventricle.

Surgical reconstruction of a patient's native valve is becoming standardfor mitral valve disease. Whether considering mitral valve prolapse,pure annular dilatation, ischemic mitral regurgitation, or mitralendocarditis, repair is now routine, highly successful, and associatedwith low late failure rates. Even in rheumatic mitral disease, manysurgeons are embarking on programs of aggressive repair, adding to ringannuloplasty the techniques of posterior leaflet augmentation withgluteraldehyde-fixed autologous pericardium, resection of the stenoticsubmitral apparatus with insertion of artificial Gortex® chords, leafletdecalcification, etc. The current goal is to achieve close to a 100%repair rate of mitral valve disorders and to markedly diminishprosthetic valve replacement. The advantages of repair versusreplacement in this setting are well documented. The operative mortalityrate (normalized for other factors) is lower, anticoagulation is notrequired in sinus rhythm, valve-related complications are less than withprosthetic valves, durability is excellent because the patient's owntissues do not degenerate, and late endocarditis is reduced because lessforeign material is present. As such, these concepts for mitral valvedisease are rapidly becoming standard-of-care in the field of cardiacsurgery.

The aortic valve of a human heart can also become diseased, with aorticvalve insufficiency occurring from a number of causes. A common cause isannular dilatation, with the sinuses of the Valsalva migrating outwardand the inter-commissural distances expanding. Geometrically, thisderangement not only increases the annular circumference, but alsoreduces the surface area of cusp coaptation. The coaptation angle of thecusps is changed essentially from being parallel and meeting at an acuteangle to pointing at each other, wherein the cusps comprise a moreobtuse arrangement. Eventually, a central gap of coaptation occurs andincreasing aortic insufficiency begets more annular dilatation whichbegets more aortic insufficiency and the leak progressively increases.

Repair of a diseased aortic valve has not been met with the same successas experienced in reconstructing a diseased mitral valve. For about 10to 15 years, the “commissural annuloplasty” technique has been used, butit can only be applied to mild-to-moderate secondary aorticinsufficiency, usually in patients undergoing primary coronary bypass ormitral valve procedures. Commissural annuloplasty not only decreasesannular circumference, but also tends to move the sinuses centrally,thus normalizing geometry and coaptation angles of the cusps. There is alimit, however, to the geometric abnormality that commissuralannuloplasty can normalize, and because the entire annulus is not fixedby this procedure, the potential for further dilatation and recurrentaortic insufficiency exists. As such, other devices and methods havebeen proposed including, for example, Carpentier et al. (U.S. Pat. No.4,451,936) which teaches a supra-annular aortic valve. According toCarpentier et al., the invention is applicable to mechanical heartvalves and leaflet-type heart valves, and does not project into theaortic valve.

In Duran et al., U.S. Pat. No. 5,258,021, an annuloplasty ring isdescribed for insertion inside the aorta in the supra-annular regionabove the aortic valve annulus. The disclosed device appears circularfrom above and has three substantially sinusoidal shaped struts.

U.S. Pat. No. 6,231,602, Carpentier et al. describes an annuloplastyring sutured to the tissue above the aortic valve annulus and also aninfra-annular ring which can be sutured to the dense tissue immediatelybelow the commissural-arterial wall intersection. Moreover, theinfra-annular ring does not alter or even influence leaflet geometry inan organized manner, but instead constricts the infra-annular aorta tomove the inferior aspects of the leaflets centrally rather than restoreproper leaflet coaptation. Furthermore, as the ring of the '602 patentis apparently based on previous studies of the mitral valve, the '602neglects the complexities of the 3-dimensional geometry of the aorticvalve and ineffectively constricts either the supra-valvular orinfra-valvular area. Also, the '602 patent describes the ring as onlyfollowing the rough shape of the aortic tissue either above or below thevalve annulus and neither provides an explanation of the proper sizingof the ring nor describes how the ring will be implanted within thepatient.

In Marquez, U.S. Published Patent Application No. 2005/0228494, a heartvalve frame is described which can separate into a plurality ofindividual cusps after implantation. Additionally, the invention of the'494 patent application is preferably used with synthetic leaflets.

Unfortunately, supra- or infra-annular rings and artificial valves ofthe prior art processes are generally not effective for the long termimprovement of the aortic valve, and additionally, may require quitecomplicated surgical procedures. The rings currently described forinsertion into the aorta are designed to be inserted above or below thevalve. Suturing a ring below the aortic valve (infra-annular) to simplydownsize or constrict the circumference will negatively distort thevalve cusps and can lead to worsening valve leak. Furthermore, theconstriction concept ignores the fact that the three semi-lunar aorticvalve cusps are three-dimensional structures that are required to meetin space in a specific orientation to provide valve competence.Similarly, the supra-annular rings of the prior art are laden with thesame problems, and have even less geometric basis, since thesupra-annular rings only quite roughly follow the shape of the aortictissue above the annulus and are based on no tangible geometric model.

What is desired, therefore, is a mounting frame which is inserteddirectly into the aortic valve annulus to repair the aortic valve.Indeed, a combination of characteristics, including a scientificallygenerated model incorporating the three-dimensional aspects of theaortic valve, has been found to be necessary for returning aorticvalvular geometry to normal. Also desired is a process for inserting andmounting such frames.

SUMMARY OF THE INVENTION

The present invention provides an intra-annular hemispherical mountingframe which is uniquely adapted to the three-dimensional characteristicsof the aortic valve. The intra-annular hemispherical mounting frameexhibits a design with careful consideration toward the anatomicalfeatures of the aortic valve anatomy so that valve competence isrestored.

In developing the intra-annular hemispherical mounting frame, multiplehuman cadaver hearts were dissected and subsequently openedlongitudinally through the commissure between the left and rightcoronary cusps. The specimens were pinned flat and measured with theannular circumference being the linear distance from one aortic marginto the other at the base of the cusps. With the annular circumferenceknown, both the annular diameter and the radius of the valve weredetermined through standard circle mathematics including the equationC=πD=2πr.

Generally the intercommissural linear distance of each cusp (C/3) wasfound to roughly approximate the annular diameter of the aortic valve(C/3.14), and the height of each cusp consistently was within about 1millimeter of the radius of the valve. Additionally, each cuspmaintained a more “shield-like” shape at the free edge with the upperaspect being slightly thicker than the rest of the leaflet. Also, theupper aspects of the leaflets at the lateral surface were flattened in acrescent shape, tapering toward the center of the leaflet and also atthe commissural insertion, creating areas of coaptation, referred toherein as “coaptation crescents.”

With the above observations, the aortic valve was circularly modeled asillustrated in FIG. 1. More specifically, the aortic valve annulus andcusps can be approximated by modeling the aorta as a center cylinder,and the valve cusps circular portions as a hemisphere of the sameradius, with the representative cusps intersecting at the center of thecylinder. Mathematically, the 3-dimensional geometry of the aorta isapproximated by modeling the hemispheres (leaflets) with radius r andcentered at (a,b,c) by the system of equations in spherical coordinates(r,θ,ϕ):x=a+r sin ϕ cos θy=b+r sin ϕ sin θz=c+r cos ϕr>0, 0≤θ<2π, 0≤ϕ≤π

Furthermore, the cylinder (aorta) with radius r can also be modeled witha system of equations in cylindrical coordinates (r,σ,z):x=r cos σy=r sin σz=zr>0, 0≤σ<2π, −∞<z<∞

Intersection of two spheres of the same radius, r, centered at(a₁,b₁,c₁) and (a₂,b₂,c₂), is the solution of the system of equations:a ₁ +r sin ϕ₁ cos θ₁ =a ₂ +r sin ϕ₂ cos θ₂b ₁ +r sin ϕ₁ cos θ₁ =b ₂ +r sin ϕ₂ cos θ₂c ₁ +r cos ϕ₁ =c ₂ +r cos ϕ₂

The intersection of a sphere of radius, r, centered at (a,b,c), and atube of the same radius is the solution of the system of equations:a+r sin ϕ cos θ=r sin σb+r sin ϕ sin θ=r cos σc+r cos ϕ=z

With the model, the two above sets of equations can be solved todetermine the points of intersection of the cusps with each other andwith the aorta so as to produce a model having points of intersection asin FIG. 2a . Such model divides the aortic circumference into thirds,allows the cusps to meet centrally, and produces lateral overlap of thecusps in the same “coaptation crescent” as observed in the dissectedspecimens. Similarly, the results can be plotted to illustrate theintersection of a plane perpendicular to the axis of the aorta and theleaflets at multiple levels, and by stacking multiple 2-dimensionalpictures, the 3-dimensional anatomy of the aortic valve leaflets can beviewed from above the valve as in FIG. 2b and from below the valve asillustrated in FIG. 2c . Furthermore, because the center of the base ofthe valve cusp hemispheres intersect the cylindrical aorta at the originand the three valve cusp hemispheres each span approximately ⅓ of thecircumference of the cylindrical aorta, a “shield shape” is produced foreach cusp as illustrated in FIG. 3. Using this model, the 3-dimensionalgeometry of the normal aortic valve annulus can be determined usingsimple mathematics, by determining the intersections of the cusphemispheres with the aortic cylinder.

Thus, the above relationships between the dimensions of the aortic valveand the cusps may be utilized in restoring valve competence. Morespecifically, the linear distance as measured on the dissected specimensis equal to about the modeled annular circumference, with the upper edgeof an individual cusp equaling about ⅓ of the annular circumference.Furthermore, the cusp height was determined to be about equal to theannular radius of the hemispherical model. By reducing annular geometryto this dimension, along with stenting the cusps to vertical andparallel, an aortic valve should be made competent, independent ofexisting root pathology. Thus, the inventive intra-annular hemisphericalmounting frame may be utilized to restore the above discusseddimensional relationships of an incompetent valve to a competent aorticvalve.

More particularly, the inventive intra-annular hemispherical mountingframe includes curvatures with curves in at least a first and a secondplane to conform to the geometry of the cusps and also interconnectingpoints to conform to the normal commissural anatomy of the aortic valve.In one embodiment, three curvatures comprise the frame with eachcurvature adjoined to the other at a pointed peak conformed to thegeometric characteristics of each commissure. In a preferred embodiment,a short post can extend up from each point to the commissure. Theseposts have a height that is equal to the equivalent radius of the aorticvalve, and would suspend the commissure and each cusp in the properthree dimensional parallel relationships to allow complete coaptation.

The frame may be constructed of a variety of materials including metals,polymers, thermoplastics, plastics, and other materials which will allowfor slight deformation but will not sheer under normal stresses.Conceivably, the frame could be a perforated strip of metal or plasticso as to allow the sutures better purchase upon mounting the frame.

Additionally, the frame may optionally be covered with a Dacron® cloth,thus utilizing the same materials as in current mitral valveannuloplasty ring designs, or alternatively, the frame may be coveredwith gluteraldehyde-fixed bovine pericardium or Gortex® material.

The intra-annular hemispherical mounting frames may embody a variety ofsizes to match the intra-cusp volume and geometry of the aortic valve ofdifferent patients. In practical use, the intra-annular hemisphericalmounting frame would range in sizes from about 16 millimeters to about30 millimeters in most patients.

Generally, the intra-annular hemispherical mounting frame can beimplanted into the aortic valve annulus in a variety of ways. A firstmethod includes small fabric strips, pledgets, or pads with acombination of mattress sutures to firmly suture the intra-annularhemispherical mounting frame to the aortic valve annulus, while reducingtearing of the aortic tissue. Alternatively, complementary single cusparcs with curvatures similar to the multiple shield curves may beemployed above the cusps into which sutures may be inserted so that thepatient's cusps would be “sandwiched” between the semi-rigidintra-annular hemispherical mounting frame and the supporting arcsabove.

An object of the invention, therefore, is an intra-annular hemisphericalmounting frame having characteristics which reconstruct the normalthree-dimensional characteristics of the aortic valve.

Still another object of the invention is an intra-annular hemisphericalmounting frame having curvatures with curves in at least a first and asecond plane so that the frame is substantially conformed to the annularcusp geometry of the aortic valve.

Yet another object of the invention is an intra-annular hemisphericalmounting frame having points interconnecting each curvature whichconform to the geometry of the area around the commissures of the valve.

Another object of the invention is an intra-annular hemisphericalmounting frame having posts corresponding to each interconnecting pointwhich assists in suspending the commissures and cusps in a properthree-dimensional relationship.

Another object of the invention is a method of implanting theintra-annular hemispherical mounting frame to the aortic valve annuluswith sutures extending from below the cusps to an area above the cusps.

Yet another object of the invention is a method of implanting theintra-annular hemispherical mounting frame which includes at least onesupport arc employed above the valve annulus similar in shape to thecurvatures of the mounting frame.

Still another object of the invention is a method of modeling theintra-annular mounting frame by measuring at least one dimension of apatient's aortic valve.

Another object of the invention is a method of sizing the intra-annularmounting frame by an integration of modeling parameters into adiagnostic device.

These aspects and others that will become apparent to the artisan uponreview of the following description can be accomplished through the useof an intra-annular hemispherical mounting frame designed withconsiderable consideration to the three-dimensional geometry of theaortic valve. The inventive intra-annular hemispherical mounting frameadvantageously reconstructs proper cusp and commissure relations so thatnormal coaptation is achieved.

It is to be understood that both the forgoing general description andthe following detailed description provide embodiments of the inventionand are intended to provide an overview or framework of understandingthe nature and character of the invention as is claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a 2-dimensional illustration of the top view of thehemispherical model of the aortic valve.

FIG. 2a is an illustration of a side-top view of a cylindrical aorticmodel.

FIG. 2b is an illustration of 3-dimensional anatomy of the aortic valveviewed from above the valve.

FIG. 2c is an illustration of 3-dimensional anatomy of the aortic valveviewed from below the valve.

FIG. 3 is an illustration of a model of a cusp.

FIG. 4 is an illustration of one embodiment of the intra-annularhemispherical mounting frame.

FIG. 5 is an illustration of a preferred embodiment of the intra-annularhemispherical mounting frame.

FIG. 6 is an illustration of a supra-valvular view of normal aorticvalve.

FIG. 7 is an illustration of a supra-valvular view of a diseased aorticvalve.

FIG. 8 is an illustration of a dissected aortic valve openedlongitudinally through a commissure.

FIG. 9 illustrates a first embodiment of the intra-annular hemisphericalmounting frame in a longitudinally opened position, overlaid on alongitudinally opened normal aortic valve and laid flat.

FIG. 10 illustrates a second embodiment of the intra-annularhemispherical mounting frame in a longitudinally opened position,overlaid on a longitudinally opened normal aortic valve and laid flat.

FIG. 11 illustrates a first embodiment of mounting the intra-annularhemispherical mounting frame opened to display a suture configurationwith an aortic valve.

FIG. 12 illustrates a second embodiment of mounting the intra-annularhemispherical mounting frame.

FIG. 13 illustrates a top view of the second embodiment of theintra-annular hemispherical mounting frame.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Although the products and methods according to the present invention aredisclosed herein as being useful for and in the context of aortic valverepair, both the products and methodology may also be used in otherfields including, but not limited to, surgical procedures for the repairof other valves within the human body.

Referring generally now to FIG. 4, an intra-annular hemisphericalmounting frame useful for aortic valve repair is shown and generallydesignated as numeral 10. Intra-annular hemispherical mounting frame 10is inserted into the aortic valve annulus and provides for thereconstruction of the native aortic valve.

Intra-annular hemispherical mounting frame 10 includes a plurality ofcurvatures 12 and also interconnecting points 14. Generally, curvature12 conforms to the annular cusp geometry with interconnecting points 14conforming to the geometry of the commissures. Curvatures 12 curve inabout a first plane and a second plane of hemispherical mounting frame10 to correspond to the three-dimensional geometry of the cusps of anaortic valve. For reference, the latitudinal plane is defined as thehorizontal plane on which intra-annular hemispherical mounting frame 10would rest with each curvature 12 contacting the latitudinal planesimilarly. The longitudinal plane is defined as the plane whichintersects the latitudinal plane at a perpendicular angle and runsvertically through intra-annular hemispherical mounting frame 10.Curvatures 12 may curve in both the latitudinal and longitudinal planesand in optional embodiments the curvatures may curve in multiple otherplanes. Preferably, curvature 12 curves in at least two planes tocorrespond to the three-dimensional geometry of the aortic valve withcurvature 12 in contact with the wall while providing support andalignment to the aortic valve cusps. Furthermore, interconnecting points14 serve the dual function of interconnecting curvatures 12 while alsoproviding support to the commissures of the aortic valve. Specifically,interconnecting points 14 are designed to closely fit thethree-dimensional geometry between adjacent cusps and locate near thecommissures thus providing support and assistance in the restoration ofthe proper coaptation of the cusps. Each point of interconnecting points14 continuously narrows into a tip so that each point fits within thenarrowing space between adjacent cusps which culminates in a commissure.As such, interconnecting points 14 provide support within thisinter-cusp space to immediately below the commissures.

FIG. 5 illustrates a preferred embodiment of intra-annular hemisphericalmounting frame 10 with posts 16 extending up from interconnecting points14. Posts 16 function as to suspend the commissures of the aortic valveas well as the cusps in proper three-dimensional parallel relationshipsto allow complete coaptation when implanted in an aortic valve.Different from the embodiment in FIG. 4, interconnecting points 14 ofthe embodiment displayed in FIG. 5. do not extend significantly into thenarrowing space between adjacent cusps, but rather posts 16 extend assuch. Otherwise stated, the tip of interconnection points 14 of FIG. 4.is at about the same height as the tip of post 16 of the embodiment inFIG. 5. In order to fully understand the design characteristics of themultiple embodiments of intra-annular hemispherical mounting frame 10,it is necessary to understand and consider the three-dimensionalrelationships within the anatomy of the aortic valve.

FIG. 6 illustrates a cross-sectional view of normal aortic valve 18 withaortic wall 20, cusps 22 and commissures 26. Aortic valve 18, while notperfectly circular in actuality, is most often within the art,prescribed measurements typically attributable to a cylindrical objectin order to provide ease in the measurements and calculations associatedwith aortic valve 18. As such, each of cusps 22 attach to aboutone-third of the circumference of aortic wall 20 while meeting incoaptation in the center of aortic valve 18. Commissures 26 are definedas the juncture points where adjacent cusps 22 attach to aortic wall 20.While FIG. 6 only illustrates the two-dimensional aspects of normalaortic valve 18, a complex three-dimensional orientation is necessaryfor both cusps 22 and commissures 26 to align in the proper coaptationas is illustrated.

FIG. 7 illustrates a cross-sectional view of a diseased aortic valvewith aortic wall 20, cusps 22, and also aortic valve leak 24. Leak 24,as illustrated in FIG. 7, may be a result of dilation of aortic annulus18, and as a result, cusps 22 do not meet in the proper coaptation.Essentially, leak 24 is a central gap of coaptation, resulting in aorticinsufficiency which in turn increases the annular dilation of aorticvalve 18 thus progressively increasing leak 24.

Turning now to FIG. 8, FIG. 8 is an illustration of a dissected aorticvalve 18, opened longitudinally through commissure 26 between two cusps22 and laid flat. Each of the three cusps 22 is illustrated as a“shield-shaped flap” with the two intact commissures 26 visible wherethe adjacent cusps 22 contact to form a point and attach to the aorticwall. Aortic valve 18 is physically characterized by annularcircumference 28 which is the measurement of the linear distance fromone aortic margin 30 to the other aortic margin 30 at the approximatebase of cusps 22. From the annular circumference, the annular diameterand annular radius can be calculated to further define the physicalgeometry of the aortic valve. Furthermore measurements include cuspheight 32 which is defined as the distance from the approximate base ofcusp 22 to upper midpoint of cusp 22 which is generally found to bewithin 1 millimeter of the annular radius in a normal functioning aorticvalve. Cusp length 34 is approximately the measurement of cusp 22 freeedge from one commissure 26 to the next and is also about equal toannular circumference 28 divided by 3 as three cusps 22 comprise thelength of annular circumference 28.

These measurements and calculations were utilized to form intra-annularhemispherical mounting frame 10 as illustrated in FIG. 3, which isfurther illustrated two-dimensionally in FIG. 9 in a longitudinallyopened position, overlaid on a longitudinally opened normal aortic valveand laid flat. While intra-annular hemispherical mounting frame 10 ofthe present invention does not open or break in practice, the twodimensional, longitudinally open view of FIG. 9 provides for greaterease in illustrating the dimensional aspects of intra-annularhemispherical mounting frame 10 in relation to aortic valve 18. Each ofthree curvatures 12 are positioned approximately adjacent to the threebases of cusps 22 of aortic valve 18. The base cusps curvatures 12 havean incident of curvature approximately similar to the curve at whichcusps 22 attach to the aortic wall. While not illustrated, in an intactaortic valve, curvatures 12 would also curve in at least one additionalplane thus corresponding to the three dimensions of an intact aorticvalve. Additionally, the two intact commissure points 14, as well as theadditional commissure point 14 not shown, fit substantially up to eachrespective commissure 26 of aortic valve 18. Intra-annular hemisphericalmounting frame 10 height 36 is the approximate distance from the base ofeach curvature 12 to each interconnecting point 14 which is similar tocusp height 32 of the aortic valve 18. Furthermore, intra-annularhemispherical mounting frame 10 length 38 is similar in geometry anddimensions to the annular circumference 28 of aortic valve 18.

In another aspect of the invention, FIG. 10 represents the embodimentillustrated in FIG. 5 in a two-dimensional longitudinally open viewsimilar to the embodiment of FIG. 4 illustrated in FIG. 9. With thisembodiment, posts 16 may extend up to the commissures 26 or slightlypast. Most preferably, posts 16 may be of a height equal to the radiusof the aortic valve 18 and may suspend the cusps in proper threedimensional parallel relationships to allow for complete coaptation ofthe aortic valve.

Generally, intra-annular hemispherical mounting frame 10 as embodied inFIG. 4 and FIG. 5 as well as in additional embodiments is substantiallysimilar in geometry and dimensions to a normal aortic valve. Most oftenthe intra-annular hemispherical mounting frame will be sized about 2millimeters less in diameter than the calculated diameter of the aorticvalve (based on the leaflet free edge length) into which theintra-annular hemispherical mounting frame will be implanted, while theincident of curvature of each of the three curvatures will be similar tothe base of the cusps or can be slightly greater or lesser, partiallydepending on whether the intra-annular hemispherical mounting frameincludes posts or not on the commissure points and also partiallydepending on the degree of abnormality of the aortic valve. Theintra-annular hemispherical mounting frame can be produced in a varietyof sizes and embodiments for providing the correct coaptation of thecusps of the aortic valve. The intra-annular hemispherical mountingframe circumferential length may be of a variety of sizes depending ofthe necessary alteration of the geometry of the diseased aortic valve.While the intra-annular hemispherical mounting frame may be consideredgenerally circular when viewed from above as illustrated in FIG. 13,which is a top view of the embodiment of the intra-annular hemisphericalmounting frame displayed in FIG. 5, the frame may include minordeviations from a circular arrangement, including deviations such asstructural flaring. Despite these deviations, the measurement typesprescribed to a cylinder will be utilized with regard to theintra-annular hemispherical mounting frame.

Most generally, the diameter of the intra-annular hemispherical mountingframe is from about 16 millimeters to about 30 millimeters with avariety of different sized frames there between, forming a gradient ofpossible choices to closely approximate the needs of the patient. Largesizes of the intra-annular hemispherical mounting frame would beproduced so that the invention could be utilized with aortic rootaneurysms or patients with Marfan syndrome. Furthermore, theintra-annular hemispherical mounting frame height as measured from thebase of a curvature to the commissure point may vary, most often beingequivalent to the calculated radius of the repaired valve. Thus, theembodiment as illustrated in FIG. 4, with the intra-annularhemispherical mounting frame of FIG. 5. would have a measurement fromthe base of the curvature to the top of a post from about (but notexclusively) 8 millimeters to about 15 millimeters. The posts on thecommissure points may be perpendicular to the longitudinal plane of theintra-annular hemispherical mounting frame and in additional embodimentsmay angle toward the interior area of the intra-annular hemisphericalmounting frame or outward away from the interior area of theintra-annular hemispherical mounting frame. The posts may extend awayfrom the interior area of the frame at an angle of from about 90 degreesto about 120 degrees when measured from the internal area of alatitudinal plane of the frame. Different orientations and shapes ofboth the posts as well as the shapes of the curvatures may be utilizedto account for the different anatomic variations. In most embodiments,the curvatures would be fairly symmetrical to one another as most valveshave 3 cusps of equal sizes, though in additional embodiments theintra-annular hemispherical mounting frame can be produced in anasymmetrical design as some patients have asymmetrical sinuses.Variations could include an intra-annular hemispherical mounting framewith one curvature about 20% larger than the other two curvatures, andalso a variation with a single curvature sized 20% smaller than theother curvatures. Additionally, the intra-annular hemispherical mountingframe may be produced with two curvatures and two interconnecting pointsfor valves where only two cusps are present. Furthermore, additionalembodiments can include a Gore-Tex® coating of the frame as well asinclude the use of a variety of different polymers to coat the frame'ssurface.

Generally, the intra-annular hemispherical mounting frame's curvaturesmay curve in at least two planes as the location of the intra-annularhemispherical mounting frame within the aortic valve necessitatescorrespondence to both the curves of the aortic wall and cusps of theaortic valve, for proper coaptation.

The intra-annular hemispherical mounting frame is comprised of metal,plastics, thermoplastics, polymers, resins or other materials which willremain intact in spite of potentially high tension caused from a highlydilated aortic roots. Preferably the intra-annular hemisphericalmounting frame may be constructed of a solid metal wire, solid plastic,and most preferably a perforated strip of metal or plastic so as toprovide the sutures better purchase once implanted into the aorticvalve. The perforations may vary depending on the installation method,though preferably with the fairly uniform geometry of the annularregion, a set number and position of perforations for sutures may becreated and marked onto the intra-annular hemispherical mounting frame.

In further embodiments, the intra-annular hemispherical mounting framemay be covered with a variety of polymers or polymer resins, includingbut not limited to polyethylene terephthalate, sold under the nameDacron® cloth. Dacron® cloth is generally employed with mitral ringsused in mitral valve repair. Alternatively, the intra-annularhemispherical mounting frame may be covered with gluteraldehyde-fixedbovine pericardium which is useful as high blood velocities in theoutflow tract of the left ventricle could possibly predispose thepatient to hemolysis with a cloth covering.

Generally, the novel intra-annular hemispherical mounting frame allowsrepair in even the most dilated aortic roots, and can permanently stentand support the three dimensional geometry of the aortic root so thatfurther dilatation and late failure would not occur. Regarding theembodiment of the intra-annular hemispherical mounting frame havingposts extending from the interconnecting points, the posts generallyhave a length of from about 70% to about 130% of the radius of theaortic valve, and are usually of about a length equal to the radius ofthe valve. More specifically, the intra-annular hemispherical mountingframe can approximate the radius of a competent aortic valve and thusincrease or decrease the valve size of the diseased aortic valve torestore valve competency. In sizing the intra-annular hemisphericalmounting frame, the top circumference of a cusp may be measured and thentripled to obtain a general circumference of the aortic valve. Mostpreferably, 2 millimeters to about 8 millimeters will be subtracted fromthis general circumference of the aortic valve to determine the framecircumference of the intra-annular hemispherical mounting frame. Thesubtraction of from about 2 to about 8 millimeters is preferable as thisundersizes the frame from about 0.67 millimeters to about 2.33millimeters per cusp and approximately from about 0.67 millimeters toabout 2.33 millimeters in diameter of the valve, thus allowing for thereorientation of the valve to provide greater cusp area of coaptationand valve competency. In this situation, suturing the commissuralaspects of the cusps to the embodiment of the intra-annularhemispherical mounting frame with posts can eliminate much of theintercommissural dimension. Generally, the intra-annular hemisphericalmounting frame will reorient the native annulus to about a diameter offrom about 16 millimeters to about 27 millimeters, and preferably offrom about 18 millimeters to about 25 millimeters in most patients,though reorienting the aortic valve to a diameter of less than about 18millimeters and lower generally will be avoided in order to preventsystolic gradients. Furthermore, the intra-annular hemisphericalmounting frame may be utilized to restore competency to prolapsedvalves, wherein the diseased valve cusp is raised up and restored to aproper orientation within the aortic wall by adjusting the spacing ofthe annular sutures in the frame.

One of the many advantages of the intra-annular hemispherical mountingframe, is the ease in which the required frame size can be determinedpreoperatively. Imaging techniques such as Magnetic Resonance Imaging(MRI) can be used, non-invasively, to determine the measurements of thepatient's aortic valve cusp free edge. More specifically, themeasurement of an aortic valve cusp, from one annular commissure to theother, should be equal to the one-third of the desired valvecircumference and also approximately equal to the annular diameter ofthe valve, with the height of each commissure roughly equivalent to theannular radius. As such, the size of the intra-annular hemisphericalmounting frame may be determined by measuring the top circumference of acusp of the aortic valve of a patient through MRI, echocardiography, orother techniques, tripling the measured top circumference of a cusp toobtain a desired annular circumference of the diseased aortic valve, andthen reducing the overall circumference with the frame to providecompetency. Typically, a frame would be selecting with a circumferencefrom about 2 mm to about 8 mm less than that calculated from the cusplength. This would provide a circumference which could be converted todiameter by which a variety of different sized intra-annularhemispherical mounting frame may be organized.

In further embodiments the imaging device, including an MRI machine andrelated controls, could include system parameters and mathematicaldescriptions of the hemispherical model which automatically take themeasurements of the patient's aortic valve and output the appropriatelysized intra-annular hemispherical mounting frame required to restorecompetency of the patient's aortic valve. Additional data output couldinclude the display of varying sized intra-annular hemisphericalmounting frames for restoring competency and the reduction in annulardiameter each different frame would create upon implantation.

Referring now to FIG. 11, there is shown intra-annular hemisphericalmounting frame 10 opened to display a suture configuration in twodimensions with aortic valve 18. Intra-annular hemispherical mountingframe 10 may have perforations 40 on curvatures 12 and posts 16 for thepassage of sutures 42 therethrough. Sutures 42 may be horizontalmattress sutures which may then pass into the aortic wall beneath theaortic valve annulus 20. In a preferable arrangement, sutures 42 wouldpass deep into the aortic wall, under cusps 22, allowing for theinsertion of intra-annular hemispherical mounting frame 10 directly intoaortic valve annulus 18 which would closely correspond to the cusps 22and commissures 26. Optionally, 3 horizontal mattress sutures may beutilized per cusp 22 and one per commissure 26 with a total of 12sutures used to implant intra-annular hemispherical mounting frame 10.Obviously, lesser or more sutures as well as other attachment techniquesknown in the art may be utilized to position and attach intra-annularhemispherical mounting frame 10 into aortic valve annulus 18. Abovevalve 18, pledgets 44 may be placed onto the mattress sutures topreclude the possible tearing of aortic tissue. Pledgets 44 may beTeflon® felt pledgets or in other embodiments not illustrated; pieces orstrips of fabric may be utilized with the mattress sutures rather thanpledgets. Preferably, pledgets 44 may be small so they would notinterfere with the mobility of the aortic valve leaflets.

Referring now to FIG. 12, there is shown an alternative embodiment forinstalling intra-annular hemispherical mounting frame 10. Support arcs46 may be employed above the valve annulus, into which sutures could beinserted. Support arcs 46 may comprise three curvatures with a shapethat is substantially similar to intra-annular hemispherical mountingframe which corresponds to the curvature and geometry of the attachmentof the cusps to the aortic wall as well as the commissures, resulting inthe annulus of the aortic valve being “sandwiched” between intra-annularhemispherical mounting frame 10 and support arcs 46. Sutures may extendthrough perforations in the intra-annular hemispherical mounting framethrough the aortic wall to the support arcs above the cusps, attachingalso through perforations in the support arcs. In additionalembodiments, the sutures may extend around the support arcs or attach inother methods known in the art.

While the novel intra-annular hemispherical mounting frame and relatedmethods of sizing and implanting the intra-annular hemisphericalmounting frame have been discussed, the invention could also be appliedto other pathologies. With aortic root aneurysms, the annuloplasty framecould allow leaflet-sparing root replacement to be performed totallyfrom inside the aorta, without the need for extensive externaldissection, as with current procedures. A non-porous Dacron® graft maybe utilized with the intra-annular hemispherical mounting frame afterbeing scalloped and flared in the graft's proximal aspect, to conform tothe sinuses of Valsalva. The size of the graft may be selected to matchthe size of the intra-annular hemispherical mounting frame, withconsideration also being given for the diameter of the distal aorta.

The coronary arteries could then would be anastomosed to the side of thegraft, either as buttons or with the inclusion technique. Using thissimple method, the aortic valve annulus would be fixed in size andgeometry, the native aortic valve would be repaired and preserved, andthe entire root and ascending aorta could be replaced for rootaneurismal disease, with much less dissection and difficulty than withcurrent techniques.

Other pathologies also could be approached. Ultrasonic debridement couldbe used adjunctively to remove spicules of calcium, and portions ofleaflets could be resected and replaced with gluteraldehyde-fixedautologous pericardium. This concept also raises the issue of aorticvalve single cusp replacement. With a method of fixing root geometrythrough reorientation, and potentially undersizing it slightly, morecomplex repairs could be undertaken, with the frame annuloplastycompensating for slight imperfections. If one cusp were severelydiseased or prolapsing, for example, the cusp could be replaced with agluteraldehyde-fixed bovine pericardial cusp (of the appropriate sizeand geometry to match the size of the frame and native cusps). Theartificial cusp could be attached to the arc above the annuloplastyframe, with the frame acting as an attachment for the arc and artificialleaflet. Alternatively, frames could be manufactured with one bovinepericardial cusp attached to one sinus. The patient's other valve tissuecould be spared, and an entirely competent valve achieved, which thenwould be two-thirds native tissue. The pericardial leaflet tissue couldbe treated with contemporary techniques for preventing calcification,but if the artificial leaflet became immobile late postoperatively, itstill could act as a coaptation baffle for the other leaflets, andpossibly not require additional operations, as can occur with totalheterograft replacement.

The intra-annular hemispherical mounting frame is unique as compared toother apparatuses used in aortic valve repair, as the intra-annularhemispherical mounting frame is designed with regard to thethree-dimensional nature of the aortic valve, providing the properanatomic geometry to the cusps and commissures to create the necessaryorientation to provide valve competence. The intra-annular hemisphericalmounting frame mounts directly to the annulus within the patient's ownvalve and returns the geometry of the cusps to a normal condition.Through the use of the intra-annular hemispherical mounting frame'sinterconnecting points and preferably, the inclusion of narrow posts(the interconnecting points), the commissural aspect of the annulus maybe raised to a proper height and orientation to produce normal cuspgeometry and coaptation.

Accordingly, by the practice of the present invention, an apparatus forrestoring normal valve geometry having heretofore unrecognizedcharacteristics is disclosed. Furthermore, the invention includes theproper sizing and multiple implantation methods of the intra-annularhemispherical mounting frame for the restoration of normal valvegeometry.

The disclosures of all cited patents and publications referred to inthis application are incorporated herein by reference.

The above description is intended to enable the person skilled in theart to practice the invention. It is not intended to detail all of thepossible variations and modifications that will become apparent to theskilled worker upon reading the description. It is intended, however,that all such modifications and variations be included within the scopeof the invention that is defined by the following claims. The claims areintended to cover the indicated elements and steps in any arrangement orsequence that is effective to meet the objectives intended for theinvention, unless the context specifically indicates the contrary.

What is claimed is:
 1. A method of repairing an aortic valve having anaortic wall, native aortic cusps, and commissures, the methodcomprising: a) providing an intra-annular mounting frame comprising aplurality of native cusp reorienting curvatures, interconnecting points,and posts, the intra-annular mounting frame corresponding to the aorticvalve and each curvature corresponding to one of the native aorticcusps, the interconnecting points connecting to the curvatures to formthe mounting frame; b) inserting the intra-annular mounting frame intoan aortic valve annulus with the curvatures positioned adjacent to wherethe native aortic cusps connect to the aortic wall; and c) suturing theintra-annular mounting frame to the aortic valve annulus with thesutures passing through the aortic wall and passing both above and belowthe native aortic cusps to implant the intra-annular mounting frame intothe aortic valve.
 2. The method of claim 1, wherein the suturing of stepc) further comprises mattress sutures.
 3. The method of claim 1, whereinthe suturing of step c) further comprises horizontal mattress sutures.4. The method of claim 3, wherein, the suturing of step c) comprisesthree horizontal mattress sutures per native aortic cusp.
 5. The methodof claim 3, wherein the suturing of step c) comprises one horizontalmattress suture per commissure of the aortic valve annulus.
 6. Themethod of claim 3, wherein the suturing of step c) comprises twelvesutures to implant the intra-annular mounting frame into the aorticvalve annulus.
 7. The method of claim 1, further comprising the suturespassing through perforations in the intra-annular mounting frame.
 8. Themethod of claim 1, further comprising the sutures passing through clothcovering the intra-annular mounting frame.
 9. The method of claim 8,further comprising the sutures passing through polyethyleneterephthalate cloth covering the intra-annular mounting frame.
 10. Themethod of claim 1, further comprising the sutures passing throughpledgets positioned above the native aortic cusps.
 11. The method ofclaim 1, wherein the pledgets comprise polytetrafluoroethylene orpledgets.
 12. The method of claim 1, further comprising restoring nativeaortic cusp coaptation of the aortic valve to proper orientation withinthe aortic wall by attaching the sutures to the intra-annular mountingframe.
 13. The method of claim 1, further comprising: d) reorienting thecusps and commissures of the aortic valve so that the aortic valve has adiameter of from about 16 millimeters to about 27 millimeters.
 14. Themethod of claim 1, further comprising: d) reorienting the native cuspsand commissures of the aortic valve so that the aortic valve has adiameter of from about 18 millimeters to about 25 millimeters.
 15. Amethod of repairing an aortic valve having an aortic wall, native aorticcusps, and commissures, comprising: a) providing an intra-annularmounting frame comprising a plurality of native cusp reorientingcurvatures, interconnecting points, and posts, the intra-annularmounting frame corresponding to the aortic valve and each curvaturecorresponding to one of the native aortic cusps, the interconnectingpoints connecting to the curvatures to form the mounting frame; b)inserting the intra-annular mounting frame into an aortic valve annuluswith the curvatures positioned adjacent to where the native aortic cuspsconnect to the aortic wall; and c) suturing the intra-annular mountingframe into the aortic valve annulus with the sutures engaging theintra-annular mounting frame from below the aortic valve and passingthrough the aortic wall and under the native aortic cusps to above thecusps to implant the intra-annular mounting frame into the aortic valveto reduce the diameter of the aortic valve.